Senior Software Quality Professional
2 days ago
This is a hybrid role with time split between hands-on software quality (around 80%) and broader quality system tasks (around 20%).
The team is developing advanced implantable technology; with a focus on safety, security, and quality at every stage of the product lifecycle.
- Main Responsibilities:
- Reviewing and approving technical documentation;
- Maintaining risk assessments and traceability matrices for software compliance;
- Collaborating with software and systems engineers to ensure secure-by-design product development;
- Supporting secure software development lifecycle and Cyber Security efforts (IEC 81001-5-1, ISO 14971, FDA Cybersecurity Guidance etc)
Requirements:
- 5+ years in software quality engineering in similar highly regulated industries;
- Experience with the relevant standards and frameworks like: IEC 62304 (medical device software - essential), ISO 14971 (risk management);
- Som knowledge of cybersecurity risk frameworks is beneficial (e.g. NIST, ISO 27001)
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